MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER SAFETY BLADES SIZE 10, STERILE; BARD-PARKER BLADE

Model Number 373910-150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that a bard-parker safety blade cut an employee.Incident occurred at the user facility.No manufacturing lot number was provided for review.End user indicated that a nurse was setting up the or and when placing the blade on the handle, the blade cover did not lock.The blade slid resulting in a laceration below the index finger.The nurse received sutures.Subsequently a hematoma formed and the hand became edematous.The sutures were removed, the area reopened, cleansed and a clot was removed.Nurse is currently recovering from scars and swelling.No manufacturing lot number was provided, therefore a review of the device history record could not be completed.Aspen surgical las piedras site has established controls to mitigate activate protected scalpel condition, including a locked position sensor that inspects one hundred percent prior to packaging.Also, un-shield testing to 10 samples at the beginning of a new lot and every 4 hours is performed until completion of the lot.Additional controls to mitigate this type of condition such as: incoming inspection procedures for handle, and shield, including visual inspection for appearance and dimensional.In-process and quality audits performed, including visual inspection to assure shield is properly assembled.Due to no sample returned and no lot number provided, the root cause cannot be determined.The incident was discussed with set-up personnel regarding incident.No further information is available on the product at this time.Sample not returned.However if any additional relevant information is identified following completion of the sample evaluation, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from the end user indicating that a bard-parker safety blade cut an employee.Incident occurred at the user facility.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: BARD-PARKER SAFETY BLADES SIZE 10, STERILE
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 8892572
• MDR Text Key: 154270368
• Report Number: 1836161-2019-00060
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 373910-150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention